Application of Model-Based Analytics in Risk-Based Monitoring

This project addresses: how can we identify clinical trial quality issues upfront, and how can we improve investigative site performance? We developed an interactive integrated analytics tool that transforms sophisticated statistical analysis into insightful information and actionable decisions. For a given risk level, the analysis identifies those investigative sites and their associated data points that exhibit higher risk potentials compared to their peers. This practice can enable the study team to target and prioritize resources around identifiable risks relating to subject safety and investigative site performance.